Valve replacement using rotational anchors

ABSTRACT

Features for a heart valve device are described. The device may include a frame with anchors configured to secure the device to tissue. The frame may include a flared end or skirt for additional securement of the implanted device. The device may include a seal such as a barrier and/or cuff for preventing leakage. The device may contract for endovascular delivery of the device to the heart and expand for securement within the heart, such as the within the native mitral valve annulus. The device may include a replacement valve. The valve may have leaflets configured to re-direct blood flow along a primary flow axis.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57.

This application is a continuation application of U.S. patentapplication Ser. No. 15/043,301, filed Feb. 12, 2016, which claims thepriority benefit under 35 U.S.C. § 119(e) of U.S. ProvisionalApplication No. 62/116,248, filed Feb. 13, 2015, the entirety of each ofwhich is hereby incorporated by reference herein for all purposes andforms a part of this specification.

BACKGROUND Field

This development relates generally to heart valves, in particular todevices, systems and methods for heart valve replacement.

Description of the Related Art

Mitral valve disease is typically repaired via invasive surgicalintervention or by complicated pinching of the leaflets togethercreating dual, smaller openings or a mitral valve replacement excludingthe native valve. The surgical approach involves risky by-pass surgery,including an opening into the patient's chest and heart chambers toexpose the mitral valve for direct viewing and repair. Resection andpartial removal of the patient's leaflets along with the implantation ofa surgical ring like a Carpentier-Edwards Physio, produced by EdwardsLife Science, are conventional but complex techniques used by surgeonsto reduce the diameter of the patient's mitral annulus, thus allowingthe leaflets to properly coapt and reducing the mitral regurgitate flow.The E-valve catheterization device described in U.S. Pat. No. 7,736,388B2 and recently approved in the U.S. attempts to duplicate a surgicaltechnique developed by Dr. Ottavio Alfieri where a connection is madeacross the mitral valve creating dual openings totaling a smaller crosssectional area for blood to flow. This technique often slightly reducesthe regurgitate flow but does not provide as durable a solution as thesurgical ring implantation. Thus, solutions to mitral valve diseasewithout these drawbacks are needed.

SUMMARY

The current device may be used as a heart valve replacement. The deviceincludes an implantable frame coupled with a valve comprising one ormore valve leaflets. The device may replace a native mitral valve. Thedevice may be delivered via catheterization, for example through avenous access in the groin and trans-septal puncture in the heartaccessing the left atrium. The device may be delivered in a collapsedconfiguration and exposed in the left atrium for expansion.

The device may include a closed-shape frame defining an axistherethorugh, with a first side and a second side opposite the firstside generally in the axial direction, with a skirt, such as a flarededge, coupled with an end of the frame. The skirt may be a flared edgeor edge portions of the frame. The frame may expand. The implantableframe may be coupled with, for example attached to, one or more valveleaflets. The leaflets may be tissue, polymer or other suitablematerials. In some embodiments, the leaflets may be coupled with theframe utilizing suturing techniques.

The device may include one or more anchors coupled with the frame. Theanchors may be elongated rods with piercing features on an end of one ormore of the anchors. The anchors may be located circumferentially aboutthe periphery of the frame, for example from the distal or proximal endof the frame. Positive securement of the frame within the mitral valvemay be achieved with the anchors engaging native tissue, such as thenative valve annulus. The anchors may follow a straight path, a curvedpath, or combinations thereof, when engaging or engaged with the tissue.The anchors may follow the path of the skirt, such as a flared edge,when engaging or engaged with tissue.

The device may include one or more seals. The seal, such as a barrier,ring, cuff or toroid, may be included, for example to prevent leakagearound the valve and/or to aid in securement of the implanted frame.

In one aspect, an implantable heart valve device is disclosed. Thedevice comprises a tubular frame having a proximal end, a distal end anda central lumen extending therethrough, with the frame comprising atleast a first pair of adjacent struts joined at a proximally facingapex, and at least a second pair of adjacent struts joined at a distallyfacing apex. The device further comprises a plurality of distally facinganchors coupled with the frame and configured to embed into tissuesurrounding a native mitral valve, a valve coupled with the frame toregulate blood flow through the central lumen, a moveable restraintcoupled with the frame and configured to restrain the frame at a desiredwidth and an annular seal carried by the frame, for inhibitingperivalvular leaks.

In some embodiments, the annular seal comprises a barrier. The barriermay be located on the interior of the frame. The barrier may be locatedon the exterior of the frame.

In some embodiments, the annular seal comprises a cuff. The cuff may beinflatable.

In some embodiments, the annular seal comprises an axially extendingbarrier and an outwardly radially extending ring.

In some embodiments, the leaflets comprise pericardial tissue.

In some embodiments, the device further comprises a plurality ofconnectors, for connecting the valve to the tubular body.

In some embodiments, the restraint comprises an aperture for receivingthe first pair of adjacent struts. The restraint may comprise a collar.The collar may comprise a threaded surface. The first pair of adjacentstruts may comprise a threaded surface.

In some embodiments, the restraint comprises a loop carried by thetubular body and surrounding the central lumen. The restraint may beconfigured to reversibly adjust the implant body radially within aworking range.

In some embodiments, advancing the collar in an axial direction reducesthe angle between the first pair of struts thereby reshaping the implantbody.

In some embodiments, the anchors are each rotatably carried by the body.

In some embodiments, the anchors are configured to be retractable.

In some embodiments, the implant body is configured to be reshaped suchthat a diameter at the proximal end is different from a diameter at thedistal end.

In some embodiments, the restraint is slidable axially along the firstpair of struts.

In some embodiments, at least one of the plurality of anchors has ahelical shape and rotating the anchor causes the anchor to extend intothe tissue.

In some embodiments, the device comprises at least four pairs ofadjacent struts and at least four apexes. The device may comprise atleast four restraints. The device may comprise at least four anchors.

In some embodiments, rotation of the anchors axially displaces theanchors with respect to the body.

In some embodiments, each strut in an adjacent pair of struts comprisesa threaded surface.

In some embodiments, the valve comprises at least a first leaflet and asecond leaflet. The first and second leaflets may be different sizes toselectively direct the direction of blood flow exiting the valve. Thevalve may further comprise a third leaflet, wherein the first leaflet islarger than both the second and third leaflets. The first leaflet may belocated on the anterior side of the valve.

In some embodiments, the distal end of the body comprises a skirt thatflares outward away from the lumen. The skirt may flare outward anddistally.

In some embodiments, the distal end of the body comprises a skirt thatflares outward and proximally.

BRIEF DESCRIPTION OF THE DRAWINGS

Elements in the figures have not necessarily been drawn to scale inorder to enhance their clarity and improve understanding of thesevarious elements and embodiments described herein. Furthermore, elementsthat are known to be common and well understood to those in the industryare not depicted in order to provide a clear view of the variousembodiments described herein, thus the drawings are generalized in formin the interest of clarity and conciseness.

FIG. 1A is a partial cross-section view of the native mitral valveanatomy of a human heart and surrounding features.

FIG. 1B is a detail view of the native mitral valve of FIG. 1A.

FIG. 1C is a perspective view of a prior art tri-leaflet valve.

FIG. 2 is a partial side view of an embodiment of a heart valve deviceincluding embodiments of a frame and distally extending anchors.

FIG. 3A is a perspective view of an embodiment of a heart valve devicehaving embodiments of a frame with an angled skirt on a distal end andwith distally and outwardly extending anchors located on a distal end ofthe frame.

FIG. 3B is a perspective view of an embodiment of a heart valve devicehaving embodiments of a frame with an angled skirt on a proximal end andwith distally and outwardly extending anchors located on a proximal endof the frame.

FIGS. 4A and 4B are perspective views of different embodiments ofanchors that may be used with the various heart valve devices describedherein.

FIG. 5 is a perspective view of an embodiment of a heart valve devicehaving a frame with a skirt, angled anchors, a mitral valve and aninterior annular seal embodied as a barrier.

FIG. 6A is a partial perspective view of an embodiment of a deliverysystem for delivering and deploying the various heart valve devicesdescribed herein using a balloon.

FIG. 6B is a partial perspective view of the system of FIG. 6A with theballoon expanded.

FIGS. 7A and 7B are partial perspective views of an embodiment of aheart valve device showing an embodiment of an interface between a frameand anchor.

FIG. 7C is a partial cross-section view of a heart valve device showingan embodiment of a curved interface between a frame and anchor.

FIGS. 8A-8B are various views of embodiments of a heart valve devicewith a valve having different sized and shaped leaflets configured forre-direction of blood flow exiting the device.

FIGS. 8C-8D are side views of the devices of FIGS. 8A and 8B showingembodiments of re-directed flow exiting the devices.

FIGS. 8E-8F are partial cross-section views of a heart mitral valve withthe embodiments of a heart valve device implanted therein forre-direction of blood flow entering the left ventricle.

FIG. 9 is a partial side view of an embodiment of a heart valve deviceshowing an interface between a frame and anchor, including a coilsurrounding a central spike.

FIG. 10 is a side view of an embodiment of a heart valve device havingan extended frame for extension into the left ventricle and exclusion ofthe native mitral valve when the device is implanted within the mitralvalve annulus.

FIG. 11 is a perspective view of an embodiment of a heart valve devicehaving a seal embodied as a woven barrier.

FIG. 12 is a perspective view of an embodiment of a heart valve devicehaving an expandable frame with angled portions and a seal embodied as abarrier.

FIGS. 13A-13C are partial cross-section views of a human heart showingan embodiment of a delivery system for delivering a heart valve devicehaving a seal embodied as a ring or cuff, such as a toroid.

FIGS. 14A-14B are partial side views of an embodiment of a heart valvedevice showing a frame with a closure system including a threadedportion and corresponding moveable restraint embodied as a collar.

FIG. 15 is a perspective view of an embodiment of a heart valve deviceshowing a frame with a closure system including threaded portions andselective placement of corresponding moveable restraint embodied as acollars.

FIG. 16 is a perspective view of a tool for holding the various heartvalve devices described herein for surgical placement or catheterdelivery of the devices.

FIG. 17 is a perspective view of an embodiment of a tool head that maybe used with the tool of FIG. 16.

FIG. 18 is a perspective view of an embodiment of a heart valve devicewith an interior annular seal embodied as a barrier and angled anchorsfor delivery and anchoring of the device from within the left ventricle,showing a delivery system driver coupled with one of the anchors.

FIGS. 19A-19B are top and perspective views respectively of anembodiment of a heart valve device having a frame embodied as a roundedring.

FIG. 19C is a perspective view of the device of FIGS. 19A-19B with avalve.

FIGS. 20A-20B are top and perspective views respectively of anembodiment of a heart valve device having a frame embodied as a“D”-shaped ring.

FIG. 20C is a perspective view of the device of FIGS. 20A-20B with avalve.

FIGS. 21A-21B are top and perspective views respectively of anembodiment of a heart valve device having a frame embodied as an oblongring.

FIG. 21C is a perspective view of the device of FIGS. 21A-21B with avalve.

FIGS. 22A-22B are partial top and perspective views respectively of anembodiment of a delivery and shaping system for delivering and shaping,for example ovalizing, the various heart valve devices described herein.

FIG. 22C is a perspective view of the system and device of FIGS. 22A-22Bwith a valve coupled with the device.

FIG. 23 is a partial perspective view of an embodiment of a piston-baseddelivery and shaping system for delivering and shaping, for exampleovalizing, the various heart valve devices described herein.

FIG. 24A-24B are partial perspective views of an embodiment of aballoon-based delivery and shaping system for delivering and shaping,for example ovalizing, the various heart valve devices described herein.

FIG. 25A-25B are partial perspective views of an embodiment of arotating shaft-based delivery and shaping system for delivering andshaping, for example ovalizing, the various heart valve devicesdescribed herein.

DETAILED DESCRIPTION

In the following discussion that addresses a number of embodiments andapplications, reference is made to the accompanying drawings that form apart hereof, and in which is shown by way of illustration specificembodiments in which the embodiments described herein may be practiced.It is to be understood that other embodiments may be utilized andchanges may be made without departing from the scope of the disclosure.

Various inventive features are described below that can each be usedindependently of one another or in combination with another feature orfeatures. However, any single inventive feature may not address all ofthe problems discussed above or only address one of the problemsdiscussed above. Further, one or more of the problems discussed abovemay not be fully addressed by the features of each embodiment describedbelow.

Various embodiments of a heart valve device are described. Relateddelivery and/or deployment systems are also described. The device mayinclude an expandable frame with anchors to secure the device to nativeheart tissue. The anchors may be aligned with an axis defined by theframe and/or angled with respect to such axis. The frame may expandand/or be shaped to securely position within a native heart valveannulus, such as the native mitral valve annulus. For instance, theframe when expanded may have a flared end or skirt that facilitates withsecure positioning of the device in the heart. The device may alsoinclude a barrier for directing blood flow. The device may include aseal to prevent leakage of blood around the device. These are some ofthe features of the device and systems described herein.

FIG. 1A is a partial cross-section view of the native mitral valve MVand left ventricle LV of a human heart. FIG. 1B is a detail view of thenative mitral valve MV of FIG. 1A. The mitral valve MV connects the leftventricle LV and the left atrium (above the mitral valve MV). The mitralvalve annulus MVA surrounds the mitral valve MV. The chordae tendineaeCT extend from papillary muscle PM of the wall of the left ventricle LVto the leaflets of the mitral valve MV. The aortic valve AV isdownstream of the mitral valve MV. During diastole of the left ventricleLV, the mitral valve MV opens to allow blood flow from the left atrium(above the mitral valve MV), through the mitral valve MV, and into theleft ventricle. The aortic valve AV closes to prevent blood flow fromexiting the left ventricle during ventricular diastole. Duringventricular systole, the mitral valve MV closes and the aortic valve AVopens to allow blood flow from the left ventricle, through the aorticvalve AV and into the aorta (above the aortic valve AV).

As shown in FIG. 1B, the mitral valve MV includes an anterior leafletand posterior leaflet surrounding the opening. The opening is surroundedby the mitral valve annulus MVA, a fibrous ring. The two leaflets arejoined at an anterior commissure at one end of the opening and aposterior commissure at the opposite end of the opening.

FIG. 1C is a perspective view of a prior art tri-leaflet valve. Thetri-leaflet valve is similar to one that would be inserted into acollapsible frame.

FIG. 2 is a partial side view of an embodiment of a heart valvereplacement device 10 having distally extending anchors 300. The device10 may include an expandable frame 100. In some embodiment, the device10 may include a valve 200 (see, for example FIG. 5). The valve 200 maybe comprised of tissue leaflets coupled with the frame 100. The device10 may have one or more distally extending anchors 300 coupled with adistal end 102 of the frame 100 for securing the frame 100 and/or valve200 within the native annulus. The device 10 may include anti-backoutfeatures to secure the device in place, such as a skirt 150 formed froma flared frame 100 end. Alternatively or in addition, the device 10 mayhave a variety of other securement features, such as anti-counterrotation anchors 300, curved-path anchors 300, or outwardlyextending/angled anchors 300, as described herein.

The frame 100 may include a proximal end 101 and a distal end 102 thatis opposite the proximal end 101. When implanted, the device 10 may beoriented such that the proximal end 101 may be closer to the leftatrium, and the distal end 102 may be closer to the left ventricle.

In some embodiments, the frame 100 may be tubular between the proximalend 101 and the distal end 102. Tubular includes any generally rounded,closed shape. For example, the frame 100 may be circular ornon-circular, as described herein. The frame 100 may have a variety ofshapes, for example “D”-shaped, oblong, oval, etc., as described herein.The shapes may be chosen in order to match a patient's anatomy.

The frame 100 may include a body 110. The body 110 may be a tubularstructure. The body 110 may define a central lumen extendingtherethrough between the proximal and distal ends 101, 102. In someembodiments, the body 110 may be formed primarily from one or more wiresor segments. The wires or segments may have a variety of cross-sectionalconfigurations, for example round, flat, polygonal, segmented, smooth,sharp, increased area, reduced area, other suitable configurations, orcombinations thereof. The wire or segments may form a series of strutsof the frame 100.

The body 110 may include the struts 110A, 110B, 110C, as shown in FIG.2. For clarity, other struts in FIG. 2 are not labelled. The frame 100may include one or more apexes, which may be formed by adjacent pairs ofstruts. Each strut in an adjacent pair of struts may comprise a threadedsurface, as described herein. As shown, there may be one or moreproximal apexes 103 located on the proximal end 101 of the frame 100 andformed, for example, by proximal vertices of the struts 110A, 110B,110C. There may be one or more distal apexes 104 located on the distalend 102 of the frame 100 and formed, for example, by the struts 110A and110B, 110B and 110C, etc. For clarity, not all apexes 103, 104 arelabelled. There may be at least four pairs of adjacent struts and atleast four apexes.

The body 110 may be separate portions coupled together. For instance,the frame 100 may be constructed from a plurality of portions of thebody 110, such as one or more struts 110A, 110B, 110C, coupled together.As shown in FIG. 2, adjacent struts may be coupled together by one ofthe anchors 300. For instance, the strut 110A may be coupled with thestrut 110B via an anchor 300. Similarly, the strut 110B may be coupledwith the strut 110C via another anchor 300. The remaining struts of theframe 100 may be similarly coupled together.

In some embodiments, the frame 100 may include openings for coupling theframe portions together. As shown, the strut 110A and strut 110B includeopenings for a shared anchor 300 to extend through the openings in arotational path. Other struts may be similarly coupled. The body 110 mayalso be formed by coupling together separate portions through welding,fusing, pins or screws to construct the frame 100.

In some embodiments, the body 110 may be integral. For example, the body110 may be formed from the same, monolithic piece of material. In someembodiments, the body 110 may be partially integral. For example, thebody 110 may be formed from several strut collections coupled together,with each strut collection including several integral struts. Theanchors 300 may be coupled with an integral or partially integral body110 as described above with respect to a frame 100 composed of separateportions coupled together.

The anchors 300 may include a body 320 and head 310. The body 320 mayextend along the length of the anchor 300. The body 320 may include apiercing end, such as a sharp tip, to pierce and engage tissue. The body320 may be a coiled configuration as shown. The head 310 may be locatedon the opposite end of the anchor 300 as the piercing tip. The head 310may include features for engaging the anchor 300 with a tool, forexample for movement of the anchor 300 into tissue to secure the device10 in place, as further described herein. The anchors 300 may be coupledwith the distal end 102 of the frame 102 and extend distally from thedistal end 102, as shown in FIG. 2.

As shown in FIG. 2, the frame 100 may be generally cylindrical in theexpanded and/or contracted configuration. The proximal and distal ends101, 102 may generally align with the struts and/or generally along anaxis defined by the frame 100. The anchors 300 may thus extend generallyaxially and/or in a similar plane as the frame 100. The anchors 300 maythus extend through the frame 100, as described, and extend generallyparallel to the axis. Thus, the frame 100 and anchors 300 may generallydefine a cylinder or other extended, tubular three-dimensional volume.

In some embodiments, features of a percutaneous aortic valve frame maybe included, for example as described in U.S. patent application Ser.No. 12/986,780 to Rowe, filed Jan. 7, 2011, the entire content of whichis incorporated herein by reference. In some embodiments, features foran adjustable endolumenal mitral valve 200 ring may be included, forexample as described in U.S. patent application Ser. No. 14/562,554 toLashinski, filed Dec. 5, 2014, the entire content of which isincorporated herein by reference.

The frame 100 may be formed from a variety of materials, including butnot limited to stainless steel, cobalt chromium, Nitinol, Nitinol alloy,other suitable implantable or implant grade materials, or combinationsthereof. The frame 100 may be constructed from a malleable material. Thedevice may be radiolucent, such that the device expansion can bemonitored via X-ray or fluoroscopy. Additional markers may be added forbetter visualization throughout the frame 100.

The frame 100 may have uniform thickness. In some embodiments, thestruts 110A, 110B, 110C may have varying thicknesses and/or widths, forexample to increase stillness or suppleness in areas of stress. Anapproximate wall thickness for a tubular frame 100 may be from about0.20 to about 1.00 millimeters in thickness. The strut 110A, 110B, 110Cwidth may be from about 0.20 millimeters to about 1.00 millimeters. Insome embodiments, the strut 110A, 110B, 110C may be about 0.50millimeters thick. In some embodiments, the strut 110A, 110B, 110C maybe about 0.75 millimeters in width. In some embodiments, a variablethickness radially and/or longitudinally may be implemented, for exampleto allow for a differential stiffness throughout the frame 100. Thethickness or thicknesses of the frame 100 may be achieved by machining,such as grinding, select areas of the frame 100 material, such as thebody 110 or struts 110A, 110B, 110C.

The frame 100 may have a variable surface topography, including but notlimited to surface contours, surface finishes, surface coatings, etc.The desired topography may be accomplished by surface grinding selectiveareas of the frame 100. The frame 100 may be electropolished, forexample after construction of the frame 100, for a smooth, passivatedsurface reducing adverse tissue interactions or reactions to elements ofthe alloy. These and other methods may also be used to implement thedesired thicknesses, as discussed above.

In some embodiments, construction of the frame 100 may include lasercutting a pattern in a small tube to define a predictable expansiongeometry. Elements of the tubular frame 100 may be removed via cuttinglaser, such as a Nd:YAG or CO2 laser. For instance, a diamond orsinusoidal pattern may be implemented, for example to allow forexpansion and contraction for implantation and delivery. Holes may bedrilled into the frame 100 for attaching of attachment features, forexample for passing suture therethrough to attach tissue and/or anchors300, as further described herein.

The frame 100 may be configured to expand. In some embodiments, theframe 100 may be configured to expand via shape memory. For example, theframe 100 may be constructed from a Nitinol alloy and heat-set to apreferred diameter or shape, thus reducing or eliminating the need for amechanical means for expansion within the deployment site.

In some embodiments, the frame 100 may be configured to mechanicallyexpand. For example, the frame 100 expansion may involve actuation. Insome embodiments, the frame 100 may be configured to fluidly expand. Forexample, the frame 100 expansion may involve hydraulic means. In someembodiments, the frame 100 may expand via a combination of mechanical,fluid, and/or other means. For instance, the frame 100 expansion may bevia a balloon or linkage to provide an internal, radial force moving theframe 100 from a collapsed configuration to an expanded configuration.Further detail of frame expansion features are provided herein, forexample with respect to FIGS. 22A-25B.

The frame 100 may have a non-uniform expansion. Non-uniform expansion ofthe frame 100 may be designed into the cut pattern. In some embodiments,a non-uniform frame 100 geometry may result, for example for a betterfit for each patient. For instance, an elliptical pattern may better fitthe mitral valve anatomy, such as the annulus shape, of a particularpatient. The eliptical resulting shape may allow, for example, for apreferential final shape, which may be more similar to a GeoFormannuloplasty ring where the Anterior-Posterior dimension is narrowerthan the Septal-Lateral dimension. In some embodiments, a vertical,geometrical undulation in the device, for example the valve 200leaflets, may be included, for example to help moving the leaflets to anormal coaptation by raising the posterior leaflet up and in from itsfallen and dilated diseased position.

The frame 100 may include various drug eluting features, such as coatingapplied to the frame 100. The drugs may prohibit or inhibit healingresponses of tissue. Such features may include Heparin, thin-filmpolymer, drug eluting, hydrophilic type, or other suitable coatings orcombinations thereof. The coatings may be loaded with a host of drugsand anti-inflammatory agents for proper healing. Pockets, holes or wellsmay be included in for example cut into, the frame 100, to form spacefor loading drugs or coatings for elusion into the surrounding area inthe body.

The device 10 may include one or more of the anchors 300. There may beat least four anchors, 300. There may be fewer or more than four anchors300. The anchors 300 may rotate. The anchors 300 may each be rotatablycarried by the frame 100. Rotation of the anchors 300 may axiallydisplace the anchors 300 with respect to the frame body 110. The anchors300 may be configured to penetrate tissue, resist bending and/or axialmovement, and perform other necessary functions. The anchors 300 may beconfigured to be retractable. The device 10 may be located within themitral valve 200 annulus and attached to native tissue via a pluralityof anchors 300. The anchors 300 may be located around the frame 100, asdescribed herein. The anchors 300 may secure the device 10 from movementrelative to adjacent tissue and/or prevent leakage around the device 10.A variety of anchors 300 may be used to secure the device including forexample a plurality of barbed spikes, as described herein.

In some embodiments, the anchors 300 may include a rotational screw,either clockwise or counterclockwise. The anchors 300 may be constructedof a wire body 320, such as round, elliptical, rectangular, othersuitable wire, or combinations thereof. The anchors 300 may be polishedsmooth, may have surface irregularities for example to limit rotation inone direction or both, other suitable features, or combinations thereof.The rotational anchors 300 may be constructed of stainless steel, cobaltchromium, polymers, other suitable implantable or implant gradematerial, or combinations thereof.

The anchors 300 may be coil-shaped, helical, and the like. The helicalanchors 300 may be constructed from a wire body 320 having across-sectional diameter from about 0.2 millimeters to about 1.0millimeters. In the coiled configuration, the anchor may have a “coileddiameter” from about 1.0 millimeters to about 3.0 millimeters. Thecoiled diameter refers to a length approximately equal to the distanceacross the resulting coil shape formed by the coiled wire as measuredperpendicular to an axis defined by the coil. The pitch of the coil maybe from about ten threads per inch to about thirty-six threads per inch.The pitch may be constant along the length of the anchor. In someembodiments, the pitch may not be constant along the length of theanchor. The axial length of the anchor, i.e. as measured along the axis,may be various suitable amounts. In some embodiments, the axial lengthmay be from about 2 millimeters to about 10 millimeters. An alternativeconstruction would be to cut a helical pattern into a coiled anchor 300with similar construction as outlined above.

The anchors 300 can be threaded into the frame 100 via openings 130,such as holes, to pass the anchor through, as discussed in furtherdetail herein, for example with respect to FIGS. 7A-7B. In someembodiments, the frame 100 may have a single through-hole connectionallowing the anchor 300 to rotate freely and move laterally within thehole. In embodiments having the anchor 300 and frame 100 withthrough-holes, for example as shown in FIGS. 3B and 5, the device 10 maydraw the frame 100 closer to the tissue when engaged into the tissue androtated.

Connecting and driving the anchors 300 can be accomplished via slottedelement, hex driver or similar means. The connection and disconnectionmeans could be pure slot and receiver, fracture-able joint or magneticconnection to hold the anchor 300 to a drive means such as a rotationalshaft located outside the patient's body. The connections could bepre-attached and loaded for delivery or attached in the body reducingthe cross sectional diameter by staggering the larger componentslongitudinally along a delivery catheter. See, for example, FIGS. 4A-4B.

In some embodiments, the anchor 300 may be a threaded rod with raised orcut threads into the periphery. The anchor 300 may function as a morestable element in the tissue resisting bending moments about theconnection axis. The additional stiffness and material within thecentral axis may require additional rotational force to drive the anchor300 into the tissue but would be a stronger point securement.Constructed from similar material as the coiled anchor 300, this shapeand form could be tapered to ease penetration forces during insertion.

A surface modification to the anchor 300 may increase the holding forceby resisting its counter rotational direction. Small barbs or surfacenicks on the anchor 300 would resist a counter rotation and loosening ofthe anchor 300 after implantation. These surface modifications could beemployed via chemical treatment or a mechanical force to cut or swageinto the anchor 300.

The anchors 300 attaching the frame 100 to the surrounding tissue couldbe parallel to the frame's 100 central axis or angled outward to directthe anchor 300 into more substantial tissue. An angle from about fivedegrees to ninety degrees from the central axis may direct the anchors300 into fibrous, myocardial tissue for additional strength andsecurement. The angles could change circumferentially depending upon theannulus tissue surrounding the anchor 300. Specifically, between thetrigonal area near the aortic valve AV, the tissue is fibrous butthinner, and therefore a more acute angle could perform better and notpenetrate the sinus of the aortic valve AV causing an unwanted leak.Conversely, opposite the trigonal area, a more obtuse angle would bebeneficial due to the thicker, more vascularized tissue in this area.Also, a deeper anchor 300 would allow additional penetration into thesofter tissue. These angular changes can be incorporated in a proximallylocated anchor 300 or distally located anchor 300 on the frame 100.

The anchor 300 positions may be variable along the height of the frame100 to direct the angle of the device 10 and/or anticipate andaccommodate the saddle shape of the native mitral valve's threedimensional shape.

The delivery of the device 10 may be via the femoral vein in the groinfor a trans-septal entry into the left atrium and down into the mitralvalve annulus MVA. The anchors 300 may be inserted into the annulus MVAfrom the left atrium (above the mitral valve). In some embodiments,delivery may be from a trans-apical entry, for example, where theanchors 300 may not be positioned in the left ventricle LV.

FIG. 3A is a perspective view of an embodiment of the heart valvereplacement device 10 having embodiments of the frame 100 with an angleddistal end 102. The device 10 of FIG. 3A may have the same or similarfeatures and/or functionalities as the device 10 described with respectto FIG. 2, and vice versa. As shown in FIG. 3A, the device 10 mayinclude distally and outwardly extending anchors 300 located on a distalend of the frame. That is, the anchors 300 are oriented angularly withrespect to an axis defined by the frame 100 and/or with respect to aplane defined by the generally tubular portion of the frame 100.

The frame 100 may have anti-backout features, such as the skirt 150.Such features may include the angled or flared distal end 102 of theframe 100 to trap the frame 100 within the valve 200 annulus from theleft ventricle LV. This feature could be a bent portion of the lowerlaser cut pattern in the frame 100 and actuated at deployment or duringthe deployment phase, for example as shown in FIG. 12. This lowerportion of the frame 100 could be angled in an upward direction towardthe left atrium resisting movement during the closure of the valve 200.The blood pressure would act on the closed valve 200, for example duringsystole, providing a force in the direction of the left atrium. Theflared lower frame 100 portion and/or the anchors 300 would resist thisforce from dislodging the frame 100 from its intended location.

FIG. 3B is a perspective view of an embodiment of the heart valve device10 having embodiments of the frame 100 with an angled skirt 150 on theproximal end 101 with distally and outwardly extending anchors 300located on the proximal end 101 of the frame. The device 10 of FIG. 3Bmay have the same or similar features and/or functionalities as otherdevice 10 described herein, such as the devices 10 described withrespect to FIGS. 2 and 3A, and vice versa. However, as mentioned, inFIG. 3B the proximal end 101 is flared to form the skirt 150. Further,the anchors 300 each extend through an opening at a vertex of the frame100 at the proximal end 101. Such an arrangement may allow forimplantation of the device 10 from within the left ventricle LV, asfurther described herein, for example, with respect to FIG. 18.

FIGS. 4A and 4B are perspective views of different embodiments ofanchors 300 that may be used with the various heart valve devices 10described herein. The anchors 300 may be rotated thus pulling the device10 into intimate contact to the surrounding tissue securing it frommovement. As shown in FIG. 4A, the anchor 300 may include the head 310having a recess 310A defined therein. A complementary shaped tool, suchas a square- or hex-head tool, may be received in the recess 310A fortransmission of rotational forces from the tool to the anchor 300. Asshown in FIG. 4B, the head 310 may be a generally flat or otherwiseuncoiled portion of the anchor body 320 that may be grabbed or otherwisesecured by a corresponding tool for similar rotation of the anchor 300.

FIG. 5 is a perspective view of an embodiment of the heart valve device10 having a frame with the flared skirt 150, angled anchors 300, animplant mitral valve 200 and an interior annular seal 400 embodied as abarrier. The device 10 has the valve 200 attached into the frame 100,with integral anchors 300 at the proximal end 101 of the device 10 andthe annular seal 400 to prevent leakage about the device 10. The valve200 includes valve leaflets 210A, 210B and 210C. The valve leaflets210A, 210B and 210C are attached along with the annular seal 400 toprohibit leakage about the device 10. The seal 400 may include the sealbody 410. The body 410 may be a thin walled structure generally forminga sidewall of the seal 400. The seal 400 is shown attached to aninterior side of the frame 100. The seal 400 is shown in dashed linesfor clarity. In some embodiments, the seal 400 may be attached to anexterior side of the frame 100. In some embodiments, there may be aninterior seal 400 and an exterior seal 400. The exterior seal 400 mayhave other configurations and embodiments, such as shown and describedwith respect to the woven barrier seal 400 of FIG. 11 or the inflatedperivalvular seal 500 of FIGS. 12 and 13A-13C.

The device 10 may include an expandable, implantable frame 100 withtissue leaflets, such as leaflets 210A, 210B and 210C, coupled with, forexample attached directly to, the frame 100. There may only be twoleaflets. The device 10 may include a plurality of connectors, forconnecting the valve 200 to the frame body 110. The mitral valve 200 maybe shaped and defined by expanding the septal lateral dimension with atool, for example to provide predictable space to place the device 10.This shaping may be defined with the frame 100 and allow intimatecontact for placement of the anchors 300 in the surrounding tissue. Atool like a Kogan Endocervical Speculum may be used to spread the tissuein an open chest placement but the spreading device may need to beconcurrent with the device 10 delivery and therefore be delivered viacatheter using a similar means.

In some embodiments, the valve 200 may be tissue. Construction of thetissue valve 200 may include cross-linked pericardial bovine or porcinetissue to fixate the material. Examples of chemical fixative agentswhich may be utilized to cross-link collagenous biological tissues mayinclude, for example, aldehydes (e.g., formaldehyde, glutaraldehyde,dialdehyde starch, para formaldehyde, glyceroaldehyde, glyoxalacetaldehyde, acrolein), diisocyanates (e.g., hexamethylenediisocyanate), carbodiimides, photooxidation, and certain polyepoxycompounds (e.g., Denacol-810, -512, or related compounds). For chemicalfixatives, glutaraldehyde may be used. Glutaraldehyde may be used as thefixative for commercially available bioprosthetic products, such asporcine bioprosthetic heart valve (i.e., the Carpentier-Edwards® stentedporcine bioprosthesis; Baxter Healthcare Corporation; Edwards CVSDivision, Irvine, Calif. 92714-5686), bovine pericardial heart valveprostheses (e.g., Carpentier-Edwards® Pericardial Bioprosthesis, BaxterHealthcare Corporation, Edwards CVS Division; Irvine, Calif. 92714-5686)and stentless porcine aortic prostheses (e.g., Edwards® PRIMA StentlessAortic Bioprosthesis, Baxter Edwards AG, Spierstrasse 5, GH6048, Horn,Switzerland).

In order to incorporate a tissue valve 200 with a stent or other type offrame 100, a number of different techniques and methods have been used,such as clamping, tying, gluing, or stitching, for example. However,many of the techniques used for this purpose generally produce a stentedvalve 200 that has concentrated stresses at the points where theleaflets are attached to the stent frame 100. That is, because thestents are relatively rigid as compared to the flexible material fromwhich the leaflets of the tissue valve 200 are made, the repetitiveflexing motion of the leaflets can create stress concentrations at thepoints where the tissue valve 200 is attached to the stent. These stressconcentrations can eventually lead to tearing of the tissue, valve 200leakage, and/or failure of the heart valve 200. The attachment pointscan also be sites for abrasion of the tissue that can lead to tearing ofthe tissue. Thus, the features described herein provide methods anddevices for a durable attachment between a tissue valve 200 and frame100 to distribute the stresses away from the attachment and seam areasand provide for nonabrasive contact surfaces for bioprosthetic heartvalve leaflets.

Polymer leaflets could also be used to construct valve 200 leaflets210A, 210B, 210C with polymers such as polyester, Teflon, urethane andcould also be reinforced with strands of stronger materials tostrengthen and improve fatigue resistance. Decell tissue anti-calciumtreatment could also be added.

FIG. 6A is a partial perspective view of an embodiment of a deliverysystem 600 for delivering and deploying the various heart valve devices10 described herein using a balloon 640. FIG. 6B is a partialperspective view of the system of FIG. 6A with the balloon 640 expanded.The device 10 may be attached to a steerable delivery system 600 and acentral balloon 640 to expand the device 10 radially larger for propersize and positioning. The system 600 may include a delivery tool 610,which may include a catheter. For example, the system 600 may include adelivery catheter with a centrally mounted balloon 640 for frame 100expansion and frame 100 connections to hold the device 10 in positionduring delivery and securement at or around the annulus. The balloon 540may be expanded to include a first portion 642 located near the tool 610and a second portion 644 located on the opposite side of the device 10.The system 600 may include one or more guides 620 for guidance of one ormore delivery wires 630. The wires 630 may attach to the frame 100, forexample at apexes of struts of the frame 100, such as the struts 110A,110B, 110C. The wires 630 may attach to the proximal end 101 of theframe 100. The proximal end 101 may form the skirt 150, such as a flaredend of the frame 100. The guide 620 may include and/or guide a driverfor rotating or otherwise moving the anchors 300. The driver may couplewith the head 310 of the anchors 300 to drive them into the tissue.

FIGS. 7A and 7B are partial perspective views of an embodiment of theheart valve device 10 showing an embodiment of an interface between theframe 100 and anchor 300. The body 110 of the frame 100 may includeopenings 130 where the coiled anchor body 310 is passed through tothread the anchor 300. The frame 100 may be formed from separateportions, such as struts, as discussed. Thus, the coiled anchor 300 mayextend through openings 130 in adjacent frame 100 portions to join thetwo frame 100 portions together. In some embodiments, the frame 100 maybe integral, as mentioned.

One or more of the anchors 300 may include one or more stoppers 330.Each anchor 300 could be assembled into the frame 100 and the stopper330 at the distal end could be installed to resist the anchor 300 frombecoming separated from the frame 100. The proximal portion would limitmovement due to the drive head. The stoppers 330 may be located at theproximal and/or distal ends of the anchors 300. The stoppers 330 maylimit rotational movement by means of a raised portion or changing thecross sectional shape of the helix.

FIG. 7C is a partial cross-section view of the heart valve device 10showing an embodiment of a curved interface interface between the frame100 and anchor 300. This interface may be used with the various devices10 described herein, for example with the skirt 150 of the device 10discussed with respect to FIG. 3A. As shown in FIG. 7C, the frame 100portion with openings 130 is shown in cross-section for clarity. Asshown, a curved or angled coil body 320 of the anchor 300 follows acurved path. This may allow, for example, to direct the rotational driveaxis in a different direction or plane than the insertion axis. Therotational or delivery drive axis refers to the direction of the toolused to drive the anchor 300. The insertion axis refers to the directionin which the anchor 300 is inserted into tissue. This may be helpful,for example, to drive in the same axis as the delivery tool yet forcethe anchors along a different, secondary axis or direction. Thus, toease delivery of the anchors 300, a portion of the frame 100, such asthe skirt 150, to hold the coiled anchors 300 may be curved or angled tochange the driving direction with respect to the tissue insertiondirection. The anchor 300 may thus be a flexible member directed throughthe series of openings 130 in the frame 100. Alternatively, a tubularmember could redirect or angle the coiled anchor 300 in variousdirections. The rotational/delivery axis and the insertion axis couldvary from about five to about ninety degrees from the axis of theannulus of the native mitral valve and/or device 10. In someembodiments, the rotational/delivery axis and the insertion axis couldvary about forty degrees from the axis of the annulus of the nativemitral valve and/or device 10.

FIGS. 8A-8F are various views of embodiments of the heart valve device10 with the valve 200, for example the valve leaflets, configured, forexample sized and/or shaped, for re-direction of blood flow exiting thedevice 10. The native mitral valve directs the flow of blood toward theposterior wall of the left ventricle LV aiding in the conservation ofthe momentum of the blood, aiding the efficiency of the heart.Conventional surgical valves used in the mitral annulus do not includethis efficiency, as the blood flow is directed into the middle of theleft ventricle LV. Therefore, in some embodiments, the device 10described herein directs the blood flow through the implanted device 200in a way that reproduces the blood flow path of the native mitral valve.

FIG. 8A is a top view of an embodiment of the device 10. In FIG. 8B, theimage on the right is a top view of an embodiment of the device 10 andthe image on the left is a side view of that device 10. FIGS. 8C and 8Dare side views of the devices 10 of FIGS. 8A and 8B showing embodimentsof re-directed flow exiting the devices 10. FIGS. 8E-8F are partialcross-section views of a heart mitral valve with the embodiments of thedevices 10 implanted therein for re-direction of blood flow entering theleft ventricle LV.

As shown in FIGS. 8A-8B, the valve 200 may include the three leaflets210A, 210B, 210C. In some embodiments, there may only be two of theleaflets. The device 10 may include the valve 200 with the leafletsconfigured, for example sized and/or positioned, to direct the bloodflow to the posterior of the heart. To re-direct the blood flow, theleaflets 210A, 210B, and/or 210C may thus be different sizes. As shown,the leaflet 210B may be larger than the leaflets 210A and 210B. Theleaflet 210B may be located on the anterior side of the mitral valve MVwhen implanted. The larger leaflet will not open as much as the othertwo smaller leaflets, directing the flow toward the smaller leafletslocated posteriorly. The same can be done with two larger leaflets andonly one smaller leaflet as well by orienting the commissure of the twolarger leaflets to the anterior of the native mitral valve.Alternatively or in addition, the blood flow may be re-directed byattaching a portion of the leaflets 210A, 210B, 210C at the sharedcommissures. The commissure attachment may prevent the leaflets fromfully opening, thus directing the outgoing flow. These or otherconfigurations of the valve leaflets, such as the valve leaflets 210A,210B and/or 210C, may re-direct blood flow exiting the device 10.

The leaflets of the valve 200 may be attached with various methods toachieve the various configurations and functions described herein.Attachment of adjacent leaflets of the valve 200 may be accomplished byconventional stitching using suture such as in an open surgicalprocedure, or by suture loops or application of clips or other tissueanchors in a percutaneous or trans apical procedure. The attachment zoneis preferably adjacent the commisure and extends no more than about 25%and generally no more than about 15% or 10% of the length of thecoaptive edges of the leaflets of the valve 200. The opposing leafletsremain unconnected to each other within a central coaptation zone,allowing the opposing leaflets to remain functioning as a single valve200. An attachment zone may be provided at a single end or at bothopposing ends of the leaflets.

In some embodiments, re-direction of the blood flow may be accomplishedwith the device 10 by orienting the device 10 when implanted such thatblood is directed by the leaflets, such as the leaflets 210A, 210B,210C, in a particular direction. In some embodiments, the valve 200 mayhave a particular arrangement of leaflets, such as leaflets 210A, 210Band/or 210C, as discussed, as well as a particular orientation whenimplanted. For example, the valve 200 may have the arrangement ofleaflets 210A, 210B, 201C as shown in FIGS. 8A-8B and the device 10 mayhave an orientation when implanted that may be generally along an axisdefined by the native mitral valve. In some embodiments, the device 10may have an orientation when implanted that may be generally off thisaxis. Thus, a method of directing the flow toward the posterior wall isto angle the attachment plane of the device 10, for example with acylindrical device 10. The flow can be appropriately directed by addingfeatures to the structure supporting the device 10, such as the frame100, that modify the attachment plane of the implanted device 100.

As shown in FIGS. 8D and 8F, the expanded frame 100 may define a centrallongitudinal axis about which the frame 100 is concentrically disposed.For example, the unconstrained expanded configuration of the frame 100may be cylindrical, frustoconical, or other shapes, and defining thecentral longitudinal axis. The device 10 may re-direct flow, asmentioned. The flow direction may be generally as shown in FIGS. 8C and8E. Further, the direction of flow, whether re-directed or not, may bealong a primary flow axis, as shown in FIGS. 8D and 8F. In someimplementations of the device 10, it may be desirable to establish theprimary flow axis inclined posteriorly at an angle “B” with respect tothe central longitudinal axis defined by the frame 10. The primary flowaxis is the general direction along which the flow travels into the leftventricle LV after exiting and/or while travelling through the device10. The angle “B” between the central longitudinal axis and the primaryflow axis may be at least about 5 degrees, and in some implementationsat least about 10 degrees, but generally less than about 45 degrees, andin some implementations less than about 20 degrees. Examples embodimentsof this angle are shown as angle “B” in FIGS. 8D and 8F.

Deflection of the primary flow axis from the central longitudinal axismay be accomplished in a three leaflet valve, for example the valve 200including the leaflets 210A, 210B, 210C, by increasing the size of theanterior leaflet, such as the anterior leaflet 210B. Example embodimentsof such a device 10 are shown in FIGS. 8A and 8B. Enlarging the anteriorleaflet, such as the anterior leaflet 210B, will displace the primaryflow axis in the posterior direction. The size of the anterior leaflet,such as the anterior leaflet 210B, may be increased such that theanterior leaflet 210B occupies an angle “A” of the circumference of thevalve 200, where the valve, whether circular or otherwise, has a totalcircumference of 360 degrees. This is shown, for example, in FIGS. 8Aand 8B (in FIG. 8B, the image on the right). In some embodiments, thesize of the anterior leaflet 210B may be increased such that theanterior leaflet occupies an angle “A” of at least about 125 degrees ofthe circumference of the valve 200. In some embodiments, the anteriorleaflet 210B occupies at least about 135 degrees, or 145 degrees, or 160degrees, or more, of the circumference of the valve 200.

FIG. 9 is a partial side view of an embodiment of the heart valve device10 showing an interface between the frame 100 and an anchor 300including a coil 320 surrounding a central spike 340. The distal spike340 may be central to the axis of the coil 320 of the anchor 300 whichrotates about the spike 340 to increase the moment, strength and fatigueresistance of the anchor 300. The spike 240 may be coupled with theframe 100, such as the distal apex 104, discussed in further detailherein, for example with respect to FIGS. 2 and 3A.

FIG. 10 is a side view of an embodiment of the heart valve device 10having an extended frame 100. The taller frame 100 extends the device 10lower into the left ventricle LV. The device 10 with extended frame 100may extend into the left ventricle LV and exclude the native mitralvalve when the device 10 is implanted within the mitral valve annulusMVA. The proximal end 101 of the frame 100 may be attached to the valveannulus and the distal end 102 may exclude the native valve.

FIG. 11 is a perspective view of an embodiment of the heart valve device10 having a woven seal 400. The woven seal 400 includes a woven sealbody 410 formed of woven material surrounding the device 10 to preventleakage around the periphery. The woven material may be constructed of apolymer fabric or a metallic wire to provide more structural integrity.Both means would be of an expandable nature to allow for varying patientanatomy. The woven seal 400 may substitute for the frame 100. That is,the woven seal 400 may take the place of the frame 100, providing bothstructural and sealing capabilities to the device 10. The anchors 300may be couple with the woven seal 400 as shown. The woven seal 400 mayhave the same or similar features and/or functionalities as the frame100, such as a flared end or skirt 150, an exterior seal 500, etc.

FIG. 12 is a perspective view of an embodiment of the heart valve device10 having an expandable frame 100. The device 10 has an expandable frame10 and anchors 300 located on the proximal end 101. An additionalfeature may be at the distal end 102 of the frame 100 to point a portioninward and proximal locking the frame 100 to the native valve annulus.The frame 100 may include one or more of the skirts 150. As shown, afirst skirt 150 may be located at the proximal end 101 and include oneor more frame tabs 112 with openings therethrough to receive the anchors300. A second skirt 150 may be located at the distal end 102 and includeone or more angled frame portions 114. The portions 114 may be locatedat the distal end 102 of the frame 100 and extend outward andproximally. The portions 114 may expand upon delivery of the device 10to secure the device 10 within the mitral valve annulus.

Depending upon the desired performance of the valve 200, one or both oftwo different types of seals may desirably be carried by the valve. Asshown in FIG. 12, the device 10 may have the seal 400. As has beendescribed herein, valve replacements in accordance with the presentdevice 10 may include a tubular support frame 100. Depending uponwhether the final implanted position of the frame 100 is primarilyextending into the left atrium, or instead extends in the ventriculardirection such as to exclude the native leaflets, the anchors 300 may becarried by the proximal end 101 (for example, atrial) or the distal end102 (for example, ventricular) of the frame 100. As a consequence, theannulus of the prosthetic valve 200 may be axially displaced along theflow path with respect to the native annulus. To prevent blood flow inthe annular space between the annulus of the prosthetic valve 200 andthe native annulus, the frame 100 is preferably provided with an annularseal 400, such as a thin sleeve or membrane, which prevents blood flowthrough the wall of the frame in between the prosthetic annulus and thenative annulus.

It may also be desirable to include structure to inhibit perivalvularleaks, for example where blood escapes around the valve 200 and/ordevice 10. A perivalvular leak may occur in between the device 10 andthe native annulus, due to potential mismatch in the geometry of thenative valve orifice and the outside diameter of the device 10. For theseal 400, relating to potential leaks through the wall of the frame 100,an impervious membrane may be carried on the inside of the frame 100 (asshown in FIG. 12), on the outside of the frame 100, or both. For theseal 500, relating to inhibiting perivalvular leaks, the barrier ormembrane will preferably be carried on the outside surface of the frame100 as will be apparent to those of skill in the art. Thus a seal 400 or500 on the outside of the frame 100 may be configured to provide bothfunctions, having an axially extending component to cover at least aportion of the length of the frame 100 including the base of theleaflets, and a radially outwardly extending or extendible component tofill spaces between the frame 100 and the adjacent anatomy.

An embodiment of a radially outwardly extending component to fill spacesbetween the frame 100 and the adjacent anatomy is the annular seal 500shown in FIGS. 13A-13C. The seal 500, such as a sealing ring, may belocated outside the frame 100, for example along a midsection of theframe 100, to limit leakage about the frame 100 as discussed. Inaddition or alternatively, the seal 500 may be located inside the frame100. The seal 500 may be active where an expansion means, such as aninflation mechanism, may increase the physical size of the seal 500.Thus, the seal 500 may have a smaller, contracted configuration duringdelivery and a larger, expanded configuration when implanted.Alternatively, the seal 500 may be passive. For example, the seal 500may self-expand upon expansion of the device 10 within the heart. Theseal 500 may include the radially outwardly extending ring component asshown, but it may also include an axially extending component to act asa barrier, as discussed above.

FIGS. 13A-13C are partial cross-section views of a human heart showingan embodiment of a delivery system 600 for delivering the heart valvedevice 10. As shown, the device 10 may include the seal 500. FIG. 13Aillustrates the device 10 being delivered veniously from the groin viatranseptal puncture to access the left ventricle LV. FIG. 13Billustrates the system 600 and device 10 with the anchors 300 insertedinto the valve annulus. FIG. 13C illustrates the system 600 and thedevice 10 with the anchors 300 inserted and the rotational anchors 300disconnected from the delivery catheter 640 with the sealing cuffinflated. Attached to the device 10 in FIGS. 13A and 13B are rotationalconnections 630 to drive the coil anchors 300 and an inflation tube 650to dimensionally change the seal 500, to limit or halt perivalvular leakthrough hydraulic pressure.

The seal 500 may be a sealing ring or cuff. The seal 500 may have thegeneral shape of a toroid or the like. To prevent leakage around theframe 100, the seal 500 may be added between the proximal portion thatresides in the left atrium (above the mitral valve) and the leftventricle LV. The seal 500 could be of a passive nature and constructedof woven fabric or velour. An alternative means could utilize a moreactive seal 500 that is inflated or expanded to meet the surroundingtissue. Construction of the active seal 500 could utilize a fluidsolution to hydraulically expand and fill with a saline or polymersolution to harden to a predetermined durometer. The seal 500 could beconstructed from a polymer balloon material such as nylon, Pebax or thelike, and filled from the handle of the delivery catheter 610. In someembodiments, the seal 500 comprises an annular skirt, such as a flangeor the like, which may be similar to the skirt 150 described withrespect to the frame 100. The skirt of the seal 500 may be attached atone end to the device 10 and inclining radially outwardly in either theproximal or distal direction. The skirt of the seal 500 may be carriedby a support structure, such as a plurality of struts. Preferably, theskirt of the seal 500 inclines radially outwardly in the distaldirection, so that ventricular pressure tends to enhance the sealingfunction between the skirt of the seal 500 and the adjacent anatomy.

In some embodiments, the seal 500 comprises an annular tube carried on aradially outwardly facing surface of the device 10, such as a surface ofthe frame 100. The tube of the seal 500 may be provided with a fillport, having a valve therein. A fill tube may extend from the deploymentcatheter, for example the tool 610, to the fill port of the seal 500,for placing the tube of the seal 500 into fluid communication with asource of inflation media, by way of an inflation lumen extendingthroughout the length of the catheter. The annular tube of the seal 500may be at least partially filled following placement, e.g. implantation,of the device 500 but prior to releasing the device 10 from thedeployment catheter. The presence of perivalvular leaks may beinvestigated by injection of contrast media and observation of theatrium under fluoroscopy. The tube of the seal 500 may be furtherinflated, or other responsive action may be taken such as repositioningthe device 10, depending upon the observed functionality. Oncefunctionality of the device 10 and level (if any) of perivalvularleakage is deemed satisfactory, the fill tube may be decoupled from thefill port of the tube of the seal 500 and the valve of the fil portclosed to retain inflation media therein, and the device 10 releasedfrom the deployment catheter.

FIGS. 14A-14B are partial side views of an embodiment of the heart valvedevice 10 showing the frame 100 with a closure system 140 including athreaded portion 142 and corresponding moveable restraint 144, such as acollar, at the proximal end 101. There may be at least four moveablerestraints 144. The moveable restraint 144 may have an aperture forreceiving therein a pair of adjacent struts of the frame 100. FIG. 14Aillustrates an initial unlocked position of a pair of struts 110A, 110Bof the body 110 from the frame 100. FIG. 14B illustrates the finallocked position of the struts 110A, 110B. The restraint 144 may beslidable axially along a pair of struts. Advancing the moveablerestraint 144, such as the collar, in an axial direction reduces theangle between the pair of struts thereby reshaping the frame 100. Asfurther shown, the pair of struts 110A, 110B may have a cable 160connecting the apexes of the struts 110A, 110B at the distal end 102,where a tension force applied to the cable 160 would draw the two apexesand anchors 300 together along with the associated tissue to which theanchors 300 are imbedded. The cable 160 may be connected to openings116A, 116B in the struts 110A, 110B. Additionally, the moveablerestraint 144, such as a collar with an aperture therethorugh, aninternally-threaded collar, nut, etc. could lock the position and/orangle of the struts 110A, 110B and relieve the tension on the cable 160.The closure system 140 could be a notched feature to hold as a threadfor a nut or a notch to hold the moveable restraint 144 in its desiredposition resisting opposing motion up the struts 110A, 110B. In someembodiments, the frame 100 may be configured to be reshaped such that awidth, for example a diameter, at the proximal end 101 is different froma width, for example a diameter, at the distal end 101.

The cable 160 or other tension element connecting adjacent struts may bereleasably grasped by a retractor element such as a pull wire extendingthrough the deployment catheter and having a distal hook, or by a sutureloop wrapping around the cable 160. Proximal retraction of the retractorelement displaces the cable 160 proximally as illustrated in FIG. 14B. Aproximal retraction element and cable 160 may be provided between eachadjacent pair of struts, or every second or third pair of struts,depending upon the desired performance. Alternatively, cable 160 maycomprise a lasso construction in which it surrounds the entire frame100, or is connected to alternating pairs of adjacent struts. One orboth ends of the cable 160 forming the lasso loop may extend proximallythrough the deployment catheter, so that proximal retraction of the atleast one end of cable 160 causes a circumferential reduction in theframe 100. In an alternate construction, cable 160 surrounds at least aportion of the frame 100 but is constructed such that cable 160 is anintegral portion of the frame 100, and remains attached to the frame 100post deployment. Circumferential reduction of the frame 100 isaccomplished by proximal retraction of a retraction element which isreleasably coupled to the cable 160, such as has been discussed above inconnection with FIG. 14B.

FIG. 15 is a perspective view of an embodiment of the heart valve device10 showing the frame 100 with several closure systems 140, includingthreaded portions 142 and selective placement of corresponding collars144. Some or all of the anchors 300 and collars 144 could be activateddepending upon the patient's need. Not all of the frame 100 vertices mayinclude the collars 144.

FIGS. 17A-17B are perspective views of a tool 700 for holding thevarious heart valve devices 10 described herein for surgical placementor catheter delivery of the devices 10. The tool 700 may include ahandle 710, body portions 720A, 720B, and corresponding tool heads 730A,730B. The tool 700 may be used for surgical placement of the frame 100,holding the tool 700 open and/or closed depending upon the positionand/or angle of the handle 710 and/or body portions 720A, 720B. Asimilar tool could be constructed for a catheter delivery viatransapical or transfemoral. As shown in FIG. 17B, the tool heads 730A,730B may include receiving poritons 731A, 731B, 732A, 732B. For example,the receiving portion 731B may receive and hold therein the strut 110Aof the frame body 110, and the receiving portion 732B may receive andhold therein the strut 110B.

FIG. 18 is a perspective view of an embodiment of the heart valve device10 with angled anchors 300 for delivery and anchoring from the leftventricle LV. The device 10 may be delivered and anchored from the leftventricle LV where the anchors 300 may be driven in from below thedevice 10 in the left ventricle LV. For example, the driver 620 mayrotate the anchors 300 from the left ventricle LV. The device 10 mayinclude the seal 400 as shown, such as an interior annular barrier, asdiscussed in further detail herein.

Defining the frame 100 diameter to match the patient's anatomy can beaccomplished by pre-defining a shaped set size using a shaped memorymaterial such as Nitinol or ballooning the malleable frame 100 materialto a defined diameter. Other means would be to close the frame 100dimensions by collapsing the frame 100 using a synching wire wrappedaround the diameter and reducing the length of the wire causing a forceto change the frame 100 shape and dimensions. Additional means wouldinclude a force to change the shape of the struts 110A, 110B on thesinusoidal frame 100 including a bending or collaring force about thestruts 110A, 110B moving the base of the frame 100 closer together andgathering the associated surrounding tissue. Additional means wouldinclude cutting threads into the frame struts 110A, 110B to mate withthe moveable restraint 144, such as a nut, advanced or rotated over thestruts 110A, 110B moving the struts closer to one another resulting in agathering force of the surrounding tissue. Another means would includethe cable 160, thread or other connection between the lower segment ofthe struts where a tensioning force would move the two struts 110A, 110Bcloser to one another. This force could be a tension in any directionincluding proximal or distal force to push or pull the cable 160 causinga gathering of the surrounding struts and associated tissue. Theconnection between the struts could be driven by a threaded means orpush/pull mechanism outside the body and through the catheter to thedevice 10.

Once the struts 110A, 110B are pulled closer to one another, the apex ofthe struts 110A, 110B can be locked or secured in place with themoveable restraint 144, such as a collar or nut, placed over the struts110A, 110B, as described herein. Locking of the struts 110A, 110B can beachieved with the closure system 140 to prevent the moveable restraint144 from moving proximally or loosening relative to the struts 110A,110B, allowing the struts 110A, 110B to move away from one another. Asmall tab may engage a ratchet surface holding the moveable restraint144 from moving proximally but allowing the moveable restraint 144 to befarther advanced if necessary. Alternatively, the moveable restraint 144could be a nut threaded over the apex holding the proximity of the twostruts 110A, 110B close to one another.

The device 10 may be shaped using these and other methods to achieve avariety of different shapes and sizes. The moveable restraints 144 maybe coupled with the frame 100 and configured to restrain the frame 100at a desired width, diameter, orientation, shape, etc. Other embodimentsof moveable restraints may be implemented, such as loops to cinch theframe 100, as discussed below. Some of these shapes, sizes,configurations, etc. are described with respect to FIGS. 19A-25B.

FIGS. 19A-19B are top and perspective views respectively of anembodiment of the heart valve device 10 having the frame 100 embodied asa rounded ring. The device 10 may include a frame 100 having a body 110with a ring shape. The body 110 may be rounded, for example circular.The device 10, in its round shape, can be placed in or around theannulus, anchored and cinched to reduce the native annulus diameter,after which the device 10 maintains its original round shape.

FIG. 19C is a perspective view of the device 10 of FIGS. 19A-19B with avalve 200. The device 10 may include a frame 100 embodied as aring-shaped body 110 coupled with, or configured to couple with, thevalve 200. The frame 100 may have the valve 200 built into it orsecondarily attached. The device 10 can be placed in the annulus,anchored, and cinched to reduce the native annulus diameter. The device10 will maintain its round shape with the valve 200.

FIGS. 20A-20B are top and perspective views respectively of anembodiment of the heart valve device 10 having a frame embodied as a“D”-shaped ring. The device 10 may include a frame 100 having a body 110with a “D” shape. The device 10 can be configured, for example shapeset, to have the shape of a “D”. The device 10 in its “D” shape, can beplaced in the naturally “D” shaped annulus, anchored, and cinched toreduce the native annulus width(s). The straight part of the “D” on thedevice may better match the natural shape and contour of the annulusalong the posterior wall.

FIG. 20C is a perspective view of the device 10 of FIGS. 20A-20B with avalve 200. The device 10 may include a frame 100 having a D-shaped body110 coupled with, or configured to couple with, the valve 200. The frame100 may have the valve 200 built into it or secondarily attached. Thedevice 10 can be placed in the annulus, anchored, and cinched to reducethe native annulus diameter. The device 10 will maintain its D shapewith the valve 200.

FIGS. 21A-21B are top and perspective views respectively of anembodiment of a heart valve device 10 having a frame 100 embodied as anoblong ring. The device 10 may include a frame 100 having a body 110with an oval-like shape. The body 110 may be rounded in the generalshape of an oval, ellipse, or the like. The device 10, in its oval-likeshape, can be placed in or around the annulus, anchored and cinched toreduce the native annulus diameter, after which the device 10 maintainsits original oval-like shape. The device 10 can be controlled thrucinching to maintain its oval shape or controlled to constrict to a morecircular configuration. Maintaining an oval shape may minimize theamount of cinching required if the apex of the long axis is aligned withthe commissures. By stretching the annulus in this direction theanterior-posterior (AP) distance is naturally decreased, which may helpreduce any regurgitation. Such cinching, with this and otherembodiments, may be done with the moveable restraint 144, which may be acollar and/or a loop. The restraint 144 may include the loop coupledwith and/or carried by the frame 100 and surrounding the central lumenof the frame 100. The restraint 144 may be configured to reversiblyadjust the size/shape of the frame 100 radially within a working range.

FIG. 21C is a perspective view of the device of FIGS. 21A-21B with avalve. The device 10 may include a frame 100 having an oval-shaped body110 coupled with, or configured to couple with, the valve 200. The frame100 may have the valve 200 built into it or secondarily attached. Thedevice 10 can be placed in the annulus, anchored, and cinched to reducethe native annulus diameter. The device 10 can maintain an oval shape orother rounded shape based on the amount of cinching.

FIGS. 22A-22B are partial top and perspective views respectively of anembodiment of a delivery and shaping system for delivering and shaping,for example ovalizing, the various heart valve devices described herein.The device 10 may include an ovalizing feature and a frame configured tobe shaped like an oval. One method for ovalizing a round ring and theannulus is to use a catheter based device to simultaneously stretch themboth along the same axis as the commisures. The device may be made of alooped, flat ribbon that has a pre-set bend to it. When the ribbon exitsthe catheter, the distal end of the loop is pulled in a proximaldirection while the proximal end of the ribbon remains stationary. Thiswill force the ribbon into a wide loop and push the device annulusoutward at the commisures to create the desired oval shape. The ovalring with a valve 200 either built into it or attached, can be placed inthe annulus, anchored, and cinched to reduce the native annulusdiameter. The device can maintain either it oval shape, or a roundedshape, based on the amount of cinching. This can be accomplished with anew functional valve 200.

FIG. 22C is a perspective view of the system and device of FIGS. 22A-22Bwith a valve coupled with the device. The oval ring with an artificialvalve 200 either built into it or attached, can be placed in theannulus, anchored, and cinched to reduce the native annulus diameter.The device can maintain either it oval shape, or a rounded shape, basedon the amount of cinching. This can be accomplished with a newfunctional valve 200.

The device 10 may include an ovalizing feature and a frame 100configured to be shaped like an oval, where the frame 100 is coupledwith, or configured to couple with, the valve 200. The frame 100 mayhave the valve 200 and/or ovalizing feature built into it or secondarilyattached. The device 10 can be placed in the annulus, anchored, andcinched to reduce the native annulus diameter. The device 10 canmaintain an oval shape or other rounded shape based on the amount ofcinching.

Some methods for ovalizing the annulus are described below. Each may beutilized with a delivery catheter.

FIG. 23 is a partial perspective view of an embodiment of a piston-baseddelivery and shaping system for delivering and shaping, for exampleovalizing, the various heart valve devices described herein. A pair ofopposing shafts with telescoping member can be used to distend theannulus in opposite directions to create an oval.

FIG. 24A-24B are partial perspective views of an embodiment of aballoon-based delivery and shaping system for delivering and shaping,for example ovalizing, the various heart valve devices described herein.A liquid filled balloon with anvil ends and a central shaft connectingthem can be used to form an oval annulus. The balloon could also beshaped like a long cylinder with round ends and having the fill portentering in the middle of the long. This type of balloon may also createenough hydraulic force to expand the annulus.

FIG. 25A-25B are partial perspective views of an embodiment of arotating shaft-based delivery and shaping system for delivering andshaping, for example ovalizing, the various heart valve devicesdescribed herein. A device that exits the delivery catheter may maintainan proximal external connection that can apply torque to two opposingshafts. As the shafts turn in opposite directions, they are extendedoutward and push against the annulus to create an oval.

While there has been illustrated and described what are presentlyconsidered to be example embodiments, it will be understood by thoseskilled in the art that various other modifications may be made, andequivalents may be substituted, without departing from claimed subjectmatter. Additionally, many modifications may be made to adapt aparticular situation to the teachings of claimed subject matter withoutdeparting from the central concept described herein. Therefore, it isintended that claimed subject matter not be limited to the particularembodiments disclosed, but that such claimed subject matter may alsoinclude all embodiments falling within the scope of the appended claims,and equivalents thereof.

It is contemplated that various combinations or subcombinations of thespecific features and aspects of the embodiments disclosed above may bemade and still fall within one or more of the inventions. Further, thedisclosure herein of any particular feature, aspect, method, property,characteristic, quality, attribute, element, or the like in connectionwith an embodiment may be used in all other embodiments set forthherein. Accordingly, it should be understood that various features andaspects of the disclosed embodiments can be combined with or substitutedfor one another in order to form varying modes of the disclosedinventions. Thus, it is intended that the scope of the presentinventions herein disclosed should not be limited by the particulardisclosed embodiments described above. Moreover, while the inventionsare susceptible to various modifications, and alternative forms,specific examples thereof have been shown in the drawings and are hereindescribed in detail. It should be understood, however, that theinventions are not to be limited to the particular forms or methodsdisclosed, but to the contrary, the invention is to cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the various embodiments described and the appended claims.Any methods disclosed herein need not be performed in the order recited.

The ranges disclosed herein also encompass any and all overlap,sub-ranges, and combinations thereof. Language such as “up to,” “atleast,” “greater than,” “less than,” “between,” and the like includesthe number recited. Numbers preceded by a term such as “approximately”,“about”, “up to about,” and “substantially” as used herein include therecited numbers, and also represent an amount or characteristic close tothe stated amount or characteristic that still performs a desiredfunction or achieves a desired result. For example, the terms“approximately”, “about”, and “substantially” may refer to an amountthat is within less than 10% of, within less than 5% of, within lessthan 1% of, within less than 0.1% of, and within less than 0.01% of thestated amount or characteristic. Features of embodiments disclosedherein preceded by a term such as “approximately”, “about”, and“substantially” as used herein represent the feature with somevariability that still performs a desired function or achieves a desiredresult for that feature.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations may be expressly set forth herein for sakeof clarity.

It will be understood by those within the art that, in general, termsused herein, are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced embodiment recitation is intended, suchan intent will be explicitly recited in the embodiment, and in theabsence of such recitation no such intent is present. For example, as anaid to understanding, the disclosure may contain usage of theintroductory phrases “at least one” and “one or more” to introduceembodiment recitations. However, the use of such phrases should not beconstrued to imply that the introduction of an embodiment recitation bythe indefinite articles “a” or “an” limits any particular embodimentcontaining such introduced embodiment recitation to embodimentscontaining only one such recitation, even when the same embodimentincludes the introductory phrases “one or more” or “at least one” andindefinite articles such as “a” or “an” (e.g., “a” and/or “an” shouldtypically be interpreted to mean “at least one” or “one or more”); thesame holds true for the use of definite articles used to introduceembodiment recitations. In addition, even if a specific number of anintroduced embodiment recitation is explicitly recited, those skilled inthe art will recognize that such recitation should typically beinterpreted to mean at least the recited number (e.g., the barerecitation of “two recitations,” without other modifiers, typicallymeans at least two recitations, or two or more recitations).Furthermore, in those instances where a convention analogous to “atleast one of A, B, and C, etc.” is used, in general such a constructionis intended in the sense one having skill in the art would understandthe convention (e.g., “a system having at least one of A, B, and C”would include but not be limited to systems that have A alone, B alone,C alone, A and B together, A and C together, B and C together, and/or A,B, and C together, etc.). In those instances where a conventionanalogous to “at least one of A, B, or C, etc.” is used, in general sucha construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, or C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that virtually any disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, embodiments, or drawings, should be understood tocontemplate the possibilities of including one of the terms, either ofthe terms, or both terms. For example, the phrase “A or B” will beunderstood to include the possibilities of “A” or “B” or “A and B.”

Although the present subject matter has been described herein in termsof certain embodiments, and certain exemplary methods, it is to beunderstood that the scope of the subject matter is not to be limitedthereby. Instead, the Applicant intends that variations on the methodsand materials disclosed herein which are apparent to those of skill inthe art will fall within the scope of the disclosed subject matter.

What is claimed is:
 1. An implantable heart valve device, comprising: atubular frame having a proximal end, a distal end and a central lumenextending therethrough; the frame comprising at least a first pair ofadjacent struts joined at a proximally facing apex, and at least asecond pair of adjacent struts joined at a distally facing apex; aplurality of distally facing anchors coupled with the frame andconfigured to embed into tissue surrounding a native mitral valve; avalve coupled with the frame to regulate blood flow through the centrallumen; and a moveable restraint coupled with the frame and configured torestrain the frame at a desired width; and an annular seal carried bythe frame, for inhibiting perivalvular leaks.
 2. The implantable heartvalve device of claim 1, wherein the annular seal comprises a barrier.3. The implantable heart valve device of claim 2, wherein the barrier islocated on the interior of the frame.
 4. The implantable heart valvedevice of claim 2, wherein the barrier is located on the exterior of theframe.
 5. The implantable heart valve device of claim 1, wherein theannular seal comprises a cuff.
 6. The implantable heart valve device ofclaim 5, wherein the cuff is inflatable.
 7. The implantable heart valvedevice of claim 1, wherein the annular seal comprises an axiallyextending barrier and an outwardly radially extending ring.
 8. Theimplantable heart valve device of claim 1, wherein the leaflets comprisepericardial tissue.
 9. The implantable heart valve device of claim 1,further comprising a plurality of connectors, for connecting the valveto the tubular body.
 10. The implantable heart valve device of claim 1,wherein the restraint comprises an aperture for receiving the first pairof adjacent struts.
 11. The implantable heart valve device of claim 10wherein the restraint comprises a collar.
 12. The implantable heartvalve device of claim 11 wherein the collar comprises a threadedsurface.
 13. The implantable heart valve device of claim 11 wherein thefirst pair of adjacent struts comprises a threaded surface.
 14. Theimplantable heart valve device of claim 1, wherein the restraintcomprises a loop carried by the tubular body and surrounding the centrallumen.
 15. The implantable heart valve device of claim 14, wherein therestraint is configured to reversibly adjust the implant body radiallywithin a working range.
 16. The implantable heart valve device of claim11 wherein advancing the collar in an axial direction reduces the anglebetween the first pair of struts thereby reshaping the frame.
 17. Theimplantable heart valve device of claim 1, wherein the anchors are eachrotatably carried by the frame.
 18. The implantable heart valve deviceof claim 1, wherein the anchors are configured to be retractable. 19.The implantable heart valve device of claim 1, wherein the frame isconfigured to be reshaped such that a diameter at the proximal end isdifferent from a diameter at the distal end.
 20. The implantable heartvalve device of claim 1, wherein the restraint is slidable axially alongthe first pair of struts.